Actively Recruiting
Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2025-12-23
44
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS.
CONDITIONS
Official Title
Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of relapsed or refractory AML or MDS/CMML meeting disease-specific criteria
- At least 7 days since last cytotoxic chemotherapy, except hydroxyurea allowed until day before lymphodepleting chemotherapy
- Localized radiotherapy allowed if additional disease sites can be assessed
- Karnofsky Performance Scale over 50%
- Adequate organ function including kidney, liver, heart, and lung as specified
- Able to provide written informed consent
- Effective birth control use for those able to have children during and up to 3 months after study
- Signed consent for long-term follow-up
- Life expectancy of 3 months or more
- HLA-A*02:01 positive by typing
You will not qualify if you...
- Positive pregnancy test in females of childbearing potential
- Significant grade 3 or higher toxicity from prior treatment
- Uncontrolled infections not responding to therapy
- Active hepatitis B or C
- Detectable HIV viral load
- Active neurological disorders
- Autoimmune disease within past 12 months
- Active central nervous system involvement by malignancy
- Active acute or chronic graft-versus-host disease requiring therapy
- Any other active malignancy except treated cervical intraepithelial neoplasia or non-melanoma skin cancer
- Serious medical conditions posing patient risk
- Major surgery within 4 weeks prior to chemotherapy
- Allogeneic stem cell transplant or donor lymphocyte infusion within 12 weeks
- Use of other investigational or anti-cancer agents
- Systemic steroids above physiologic doses or recent use of certain immune therapies
- Immunosuppressive therapy such as steroids or calcineurin inhibitors at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jeremy Ramdial, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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